HS40 Diagnostic Ultrasound System

K180409 · Samsung Medison Co., Ltd. · IYN · May 11, 2018 · Radiology

Device Facts

• Record ID: K180409
• Device Name: HS40 Diagnostic Ultrasound System
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HS40 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Story

HS40 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays it in various modes: 2D, M-mode, Color/Power Doppler (including S-Flow), PW/CW Spectral Doppler, Harmonic imaging (S-Harmonic), Tissue Doppler, Panoramic, Freehand 3D, and real-time 4D. Used in clinical settings by healthcare professionals to visualize anatomical structures, perform measurements, and utilize analysis packages for diagnosis. The system automatically displays mechanical and thermal indices for acoustic output. It supports digital image capture, review, and reporting. Benefits include non-invasive diagnostic imaging and guidance for procedures like biopsies.

Clinical Evidence

No clinical studies were required to support substantial equivalence. The device relies on bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal/electromagnetic/mechanical safety testing in accordance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD 2, NEMA UD 3).

Technological Characteristics

Mobile diagnostic ultrasound system; supports B, M, PW/CW Doppler, Color/Power Doppler, Harmonic imaging, Tissue Doppler, 3D/4D imaging, and Elastoscan. Connectivity includes digital image capture and reporting. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2, and NEMA UD 3. Software-controlled; materials evaluated for biocompatibility.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis of the human body in fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac, and peripheral vessel applications.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• HS40 Diagnostic Ultrasound System (K172129)
• Sonoace R7 Diagnostic Ultrasound System (K133505)
• LOGIQ S7 Expert Diagnostic Ultrasound System (K160182)

Submission Summary (Full Text)

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May 11, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Samsung Medison Co. Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do. 25108 REPUBLIC OF KOREA

Re: K180409

Trade/Device Name: HS40 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 13, 2018 Received: April 16, 2018

Dear Ji Yea Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180409

Device Name HS40 Diagnostic Ultrasound System

#### Indications for Use (Describe)

The HS40 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

### Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)

Page 1 of 1

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510(k) Premarket Notification - Traditional

Image /page/3/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly upwards from left to right.

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

### Device Name: HS40 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|------------|---------------------------------------------------|---|-----|-----|-------------------|-------------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11 | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11, 12 | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Note 8, 9, 11 | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | P | P | P | | P | Note 1 | Note 2, 7, 9, 12 | |
| Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7, 14 | |
| | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7, 14 | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

{4}------------------------------------------------

510(k) Premarket Notification – Traditional

Image /page/4/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

#### Device Name: LA3-16AD for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|----------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11, 12 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11, 12 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 7, 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K172129(LA3-16A) ; E= added under Appendix E

#### Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

- Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan Note 13: Includes Urology/Prostate
- Note 14: Tissue Doppler Imaging (TDI)

Note 2: Includes imaging for guidance of biopsy

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

{5}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/5/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-8AD for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K172129; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

{6}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/6/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CF4-9 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|-------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K172129; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

- Note 12: ElastoScan
Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

{7}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/7/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PN2-4 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|-----------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 7 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>&<br>Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | Note 1 | Note 7 | |
| | Trans-rectal (See Note 13) | | | | | | | | |
| | Trans-vaginal (See Note 13) | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| | Cardiac Adult | P | P | P | | P | Note 1 | Note 4, 7, 14 | |
| Cardiac | Cardiac Pediatric | P | P | P | | P | Note 1 | Note 4, 7, 14 | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared by FDA K172129; E= added under Appendix E

#### Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

- Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 2: Includes imaging for guidance of biopsy

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

{8}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/8/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EVN4-9 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 9 |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 9 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 9, 12 |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 9, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 9, 12 |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K172129; E= added under Appendix E

#### Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

- Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 2: Includes imaging for guidance of biopsy

{9}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/9/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VN4-8 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|---------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by K172129; E= added under Appendix E

#### Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

- Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan

Note 2: Includes imaging for guidance of biopsy

Note 13: Includes Urology/Prostate Note 14: Tissue Doppler Imaging (TDI)

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

{10}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/10/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V5-9 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|----------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | | |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Other (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |

N= new indication: P= previously cleared by FDA K172129; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

{11}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/11/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside a blue, rounded, oval shape.

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

#### Device Name: DP2B for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | | |
| | Abdominal (See Note 12) | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared by FDA K172129; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

{12}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/12/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance. The font used for the word "SAMSUNG" is bold and sans-serif.

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

#### 510(k) No.:

#### Device Name: C2-8 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7,8, 9, 11 | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 6, 7, 8, 9, 11 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared by FDA K133505; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
- Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: Tissue Doppler Imaging (TDI)

{13}------------------------------------------------

510(k) Premarket Notification - Traditional

Image /page/13/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

#### 510(k) No.:

#### Device Name: C2-5 for use with HS40

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|-------------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 6, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K133505; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monit…